On February 25, The Wall Street Transcript interviewed George B. Zavoico, an Equity Research Analyst at Cantor Fitzgerald specializing in micro and small cap biotechnology, specialty pharmaceuticals, and molecular diagnostics companies with an interest in the cancer, cardiovascular, autoimmune and inflammatory disease therapeutic areas. Key excerpts follow:
Dr. Zavoico: Let me bring up Poniard Pharmaceuticals (OTCPK:PARD). They have a third-generation, platinum-based, anti-cancer drug called picoplatin. They are conducting a Phase III clinical trial in small cell lung cancer right now. Phase II trials already showed an extension of median survival. Phase III trial results are expected toward the end of this year. With promising Phase II results, I suspect the Phase III trial, which is being conducted under an SPA with the FDA, will show similar results. Small cell lung cancer is a particularly tough disease once it recurs. The response rate for first-line therapy is generally pretty good, but most patients will eventually die from recurrent disease. Studies show that median survival after recurrence in patients who have failed to respond to platinum therapy is about 13-14 weeks with best supportive care. Median survival is prolonged to about 17-22 weeks in these resistant or refractory patients if they receive second-line, or salvage chemotherapy. In Poniard's Phase II trial with picoplatin, median survival was extended to about 27 weeks.
TWST: Is that enough to get the FDA moving on it?
Dr. Zavoico: I believe so. Remember, this trial is being conducted under an SPA with the FDA, so I believe they are aware of the expectations.
TWST: I thought they are getting a little tougher on some of these end-stage results that weren't meaningful?
Dr. Zavoico: This is an unmet clinical need so I think this one has a very good chance if the trial meets expectations.
TWST: What's the timeline on it?
Dr. Zavoico: This trial is called SPEAR. Poniard projects enrollment to be complete in the first half of this year, with the results becoming available in the fourth quarter. An NDA will probably be submitted in early 2009, if the trial ends on schedule. FDA approval, assuming the trial meets expectations, could happen in late 2009 or 2010.
TWST: How big a market is this potentially?
Dr. Zavoico: Small cell lung cancer is relatively small compared to non-small cell lung cancer. It's about 15% to 20% of all lung cancer cases. But Poniard is also developing picoplatin for the treatment of colorectal cancer and hormone-refractory prostate cancer. A Phase II trial for the first-line treatment of metastatic colorectal cancer commenced last November and a Phase II trial for the first-line treatment of hormone refractory prostate cancer, in combination with docetaxel and prednisone, commenced last July. In January, Poniard announced safety data from a Phase I dose-escalation trial of picoplatin in colorectal cancer. The data showed that picoplatin has a superior safety profile relative to oxaliplatin, the current standard of care. Oxaliplatin, which is Sanofi's (NYSE:SNY) Eloxatin, has been shown historically to induce neuropathy in about 80% of patients, about 20% of it being severe neuropathy. In the Phase I trial with picoplatin, about 20% of patients had mild neuropathy, and no patients had severe, grade 3 or 4 neuropathy. It's quite possible that picoplatin might become the preferred standard of care in this almost $2 billion market if the safety data holds up. That's why I believe picoplatin is an exciting compound.
TWST: Are other people working in the same space?
Dr. Zavoico: Yes, satraplatin was another third-generation platinum compound that was being developed by Spectrum Pharmaceuticals (NASDAQ:SPPI) and GPC Biotech (GPCB), a German company, for the treatment of hormone-refractory prostate cancer. GPC had filed an NDA with the FDA based on progression-free survival, but the FDA voted to delay approval until overall survival results were available. Consequently, GPC withdrew the NDA.
TWST: So it gives Poniard an edge then?
Dr. Zavoico: Yes, I think so.